Food and Drug Administration
agency of the US Department of Health and Human Services
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01.07.2024Labour Party wins the general election
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society 2025-07-03 09:34
FDA vaccine official imposes new limits on COVID vaccine approvals - Dr. Vinay Prasad imposed restrictions on COVID vaccine approvals for Novavax and Moderna, despite prior analyses by FDA scientists suggesting broader access.
- The decision to limit vaccine availability to specific high-risk groups reflects ongoing tensions within the FDA regarding vaccine safety and effectiveness.
- These actions raise concerns about the public health implications of restricting COVID vaccine access amid ongoing health threats posed by the virus.
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society 2025-06-20 00:00
FDA gives risky drugs from banned factories a pass - ProPublica's investigation revealed the FDA allowed over 150 drugs from factories with manufacturing violations into the U.S. market.
- The FDA claimed these drugs were deemed safe after additional testing but faced criticism for not informing the public of the exemptions.
- The practice raised concerns about public health and the integrity of the FDA's regulatory process.
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society 2025-06-19 04:44
New Zealand approves psilocybin to treat depression - New Zealand has approved psilocybin for therapeutic use by select psychiatrists.
- This decision allows for the treatment of patients with treatment-resistant depression.
- The approval reflects a broader trend in recognizing psychedelics for mental health treatments.
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society 2025-06-04 15:39
FDA commissioner reviews safety of abortion drug mifepristone amid concerns - Marty Makary, FDA Commissioner, announced a review of mifepristone safety after a concerning study.
- The study indicated that 11% of women experienced severe side effects, substantially higher than current labeling.
- The review may lead to potential changes in regulations regarding medical abortion drugs.
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society 2025-06-04 10:00
FDA raises tomato recall to highest risk after deadly contamination fears - H&C Farms Label tomatoes were linked to a salmonella contamination risk, prompting a recall.
- The FDA elevated this recall to a Class I designation due to the serious health risks involved.
- Consumers are advised to discard any affected tomatoes to prevent potential illness.
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society 2025-05-31 17:05
FDA approves Moderna's new lower-dose COVID-19 vaccine with usage limits - The FDA approved Moderna's new COVID-19 vaccine, mNexspike, with specific usage limits for certain age groups.
- The approval was based on a study demonstrating the new vaccine's safety and effectiveness compared to the existing vaccine.
- This new low-dose vaccine aims to protect those at higher risk and represents a strategic shift in COVID-19 vaccination policies.
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society 2025-05-23 15:10
FDA advisors select strain for this year's COVID vaccine - Expert advisors for the FDA met to select a strain for updated COVID-19 vaccines ahead of the vaccination season.
- The advisors voted unanimously to target the JN.1 lineage, stemming from WHO recommendations, amidst discussions about the possible need for new trials.
- There are significant regulatory uncertainties and ethical concerns regarding the implementation of new vaccine formulations, highlighting the importance of swift decision-making.
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business 2025-05-22 16:19
Federal officials seize $34 million in illegal e-cigarettes from China - Federal officials seized nearly $34 million worth of illegal e-cigarettes in February from China.
- The FDA has warned 24 companies and issued over 750 warning letters to unauthorized vendors.
- The ongoing crackdown aims to protect youth from unauthorized vaping products.
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technology 2025-05-22 00:00
FDA announces generative AI deployment by June 2025 - The FDA plans to implement generative AI technology agency-wide by June 2025.
- This technology aims to improve document review and regulatory compliance tracking.
- The successful pilot of AI in scientific reviews has led to an accelerated timeline for its broader adoption.
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society 2025-05-21 13:16
FDA narrows COVID-19 vaccine access to older adults and high-risk groups - The FDA has introduced new approval standards for COVID-19 vaccines prioritizing older adults and high-risk populations.
- Future vaccinations for healthy individuals will rely on more rigorous clinical evidence, limiting their access to new vaccines.
- This policy change could significantly reduce vaccination availability for younger, healthier demographics, causing ongoing public health concerns.
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business 2025-05-07 00:00
Hamdi Ulukaya invests $1.7 billion to transform dairy farming - Hamdi Ulukaya announced a $1.2 billion investment for a new dairy facility in New York.
- He has also committed an additional $500 million to expand operations in Idaho.
- These investments aim to improve food accessibility and quality in the dairy industry.
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society 2025-05-06 19:48
Vinay Prasad takes charge of FDA's biologics and vaccines division amid controversies - Dr. Vinay Prasad is appointed to lead the FDA's Center for Biologics Evaluation and Research.
- He replaces Dr. Peter Marks, who resigned due to concerns over vaccine safety policies.
- Prasad's critical stance on vaccines may influence future FDA vaccine regulations.
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science 2025-05-06 19:48
Vinay Prasad takes charge of FDA vaccine program amidst controversy - Dr. Vinay Prasad has been named the head of the FDA's Center for Biologics Evaluation and Research.
- His appointment is part of a trend of bringing critics of conventional medical practices into government roles.
- Concerns have been raised that Prasad's leadership may lead to increased scrutiny of vaccines and hinder their approval.
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technology 2025-05-06 12:42
Avant Technologies and Ainnova set for crucial FDA meeting on Vision AI platform - The FDA has scheduled a pre-submission meeting for Avant Technologies and Ainnova on July 7, 2025.
- The meeting will focus on the planned clinical trial for Ainnova's Vision AI platform technology.
- Successful engagement with the FDA is crucial for the commercial potential of Ainnova's technology in the U.S. market.
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business 2025-05-05 00:00
California lettuce industry elevates safety standards amid FDA challenges - The California Leafy Greens Marketing Agreement governs rigorous food safety standards to prevent foodborne illnesses.
- Members of LGMA represent about 98% to 99% of California's lettuce production, equating to over 55 billion servings consumed annually.
- Despite high compliance, localized foodborne outbreaks have raised concerns, highlighting the importance of continuous safety improvements.
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society 2025-05-02 00:00
FDA plans to reinstate fired employees amid staffing crisis - The FDA has announced plans to rehire some of the staff members recently laid off amid significant budget and departmental changes.
- Mass layoffs led to confusion and uncertainty about employee status and operational capabilities.
- The reinstatement reflects ongoing efforts to address disruptions and challenges in maintaining essential government functions.
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science 2025-04-29 12:00
Biomay secures FDA approval for Cas9 nuclease production - Biomay received FDA approval for manufacturing recombinant Cas9 nuclease at its headquarters in Vienna, Seestadt.
- The approval came after an FDA inspection found no observations, allowing the site to supply the U.S. market.
- This achievement underscores Biomay’s commitment to high-quality manufacturing standards in the biotechnology sector.
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science 2025-04-13 11:47
Trump administration announces end to cruel animal testing practices - The Trump administration has announced plans to phase out animal testing for drug development at both the FDA and EPA.
- This shift replaces traditional animal testing with AI-based and human organ models, aiming to expedite safer treatments.
- Animal advocacy groups praise these changes, yet some experts caution that humane animal testing still plays a crucial role.
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society 2025-04-04 18:44
Trump administration dismantles FDA's bird flu response team amid outbreak - The Trump administration cut members of the FDA’s bird flu response team despite rising case numbers.
- These layoffs removed critical personnel responsible for managing and monitoring bird flu outbreaks.
- Experts warn that the combination of staff reductions and bird migration may lead to increased risks for new virus variants.
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society 2025-04-03 21:30
Cromer Food Services recalls chicken salad sandwiches over undeclared milk allergens politics 2025-04-03 01:15
Supreme Court backs FDA's ban on flavored e-cigarettes - The U.S. Supreme Court ruled in a 9-0 unanimous decision favoring the FDA's authority over flavored vaping products.
- This decision affirms the FDA's position that flavored e-cigarettes are particularly appealing to minors and pose health risks.
- The ruling establishes a precedent for future FDA regulatory actions regarding tobacco products and flavored e-cigarettes.
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society 2025-03-30 00:00
Thousands of pounds of ground coffee recalled for mislabeling as decaffeinated - The FDA recalled thousands of ground coffee packages due to a labeling error.
- The recall affects coffee sold in 15 states, impacting over 4,152 packages.
- Consumers are urged to check their coffee for correct labeling to ensure safety.
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politics 2025-03-26 15:06
Marty Makary confirmed as FDA commissioner amid scrutiny - The Senate confirmed Marty Makary as FDA commissioner with a vote of 56-44.
- Concerns about his stance on abortion and vaccination regulation arose during confirmation hearings.
- Makary's appointment signals a shift in federal health policies under the Trump administration.
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society 2025-03-18 17:51
FDA employees face chaos while returning to office under new mandate - Thousands of FDA employees returned to their headquarters as mandated by the federal government.
- Employees encountered severe logistical problems, including long security lines, no office supplies, and overflowing parking.
- The chaotic situation reflects a lack of preparation for the sudden shift back to in-person work amid ongoing safety concerns.
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society 2025-02-25 03:45
FDA fires and rehired hundreds of staff amid chaos - The Food and Drug Administration recently fired a large number of staff members, particularly from its medical devices center.
- These firings were part of a broader initiative led by the Department of Government Efficiency under Elon Musk.
- The subsequent rehiring of some employees indicates the ongoing need for experienced staff within the agency.
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society 2025-02-19 00:00
FDA prioritizes ideology over drug safety under Biden administration - The FDA has faced criticism for prioritizing ideology over drug safety.
- Recent studies show significant risks associated with puberty blockers and cross-sex hormones.
- There is a pressing need for the FDA to ensure independent and transparent drug safety monitoring.
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science 2025-01-30 00:30
FDA expands Ozempic's use to combat chronic kidney disease in diabetes patients - The FDA approved Ozempic for treating chronic kidney disease in Type 2 diabetes patients, allowing it to mitigate the risk of worsening kidney function.
- This decision may change how healthcare providers treat chronic kidney disease, which often coexists with diabetes.
- Ozempic's approval signifies broader health benefits of GLP-1 medications in addressing metabolic-related health issues.
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society 2025-01-07 15:26
FDA introduces lead limits in baby foods to protect infants - The FDA has established maximum lead levels in baby foods for the first time, aiming to reduce children's exposure.
- Consumer advocates argue the new guidance is insufficient and does not cover all food categories with potential lead contamination.
- Despite this initial step, critics emphasize the need for more stringent regulations to eliminate lead exposure in children's foods.
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society 2024-12-28 08:20
FDA demands action to ban asbestos from talc cosmetics - The FDA has proposed a new rule mandating standardized testing for asbestos in talc-containing cosmetics.
- This rule aims to protect consumers from potential health risks associated with asbestos exposure.
- Implementation of these standards comes amid numerous lawsuits against major companies like Johnson & Johnson for alleged links between talc and cancer.
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society 2024-12-23 14:06
FDA admits phenylephrine decongestant doesn't work—what now? - The FDA has proposed revoking the use of phenylephrine in over-the-counter cold and allergy medications.
- Research has indicated that phenylephrine, even at high doses, is ineffective in treating nasal congestion.
- Consumers may need to seek alternatives as drug manufacturers begin to reformulate their products.
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society 2024-12-20 21:44
FDA approval of Zepbound sparks debate over weight loss solutions - The FDA approved Zepbound, a weight loss drug, to treat obstructive sleep apnea in adults with obesity.
- The approval is based on clinical trials demonstrating significant weight loss and symptom reduction among participants.
- This development may lead to broader insurance coverage and increased awareness about sleep apnea and its health risks.
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business 2024-12-16 06:05
MannKind pushes for FDA approval in 2025 amid diabetes treatment controversy - MannKind Corporation announced the results of a Phase 3 study of its inhaled insulin product Afrezza in pediatric patients aged 4-17.
- The trial showed non-inferiority of Afrezza to MDI, with no significant differences in lung function between treatment groups.
- MannKind plans to meet with the FDA to discuss a potential sNDA submission in the first half of 2025.
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2023 All rights reserved